Job Summary

This role will report into a line manager within Global Trial Management. The GTA can potentially support any therapeutic areas and research phase and will collaborate with cross-functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report.

Responsibilities

- Contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities regulations/guidelines, and applicable SOPs/WPs.
- Provides operational input on development, management and maintenance of study deliverables (i. e. timelines, study plans, documents, etc. ) through collaboration with internal and external stakeholders.
- Primarily works on routine to complex projects/trials at varying stages and supports multiple complex trials as needed.
- Contributes to achieving corporate and study team goals, successfully completes assigned tasks, participates in service provider oversight, and sets priorities with guidance.
- Manages the development and/or collection of study level documentation and support Global Trial Lead (GTL) in ensuring eTMF accuracy and completion for all studies.
- Proactively manages multiple assignments and operational processes with moderate to minimal supervision.
- Manages country planning, protocol level attributes and milestones/drivers in CTMS.
- Has high functional impact on the study team and the organization.
- Support Global Trial Lead (GTL) in tracking of non-clinical supplies




- Support Global Trial Lead (GTL) in vendor management related activities

Project Management

- Manages the development and/or collection of study level documentation support Global Trial Lead (GTL) in ensuring eTMF accuracy completion of for all studies
- Provides operational input and facilitates operational processes as an SME in support of the startup, maintenance, and closure of studies.
- Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution.
- Proactively Identifies risks and develops/implements action to avoid or mitigate.
- Resolves routine problems and escalates key issues appropriately (with a sense of urgency).
- Actively contributes as a key functional member on cross-functional teams.

Study/Project Planning, Conduct and Management

- Provides and support input to study level tools and plans while working with moderate to minimal supervision, including but not limited to the Transfer of Obligations to Regulatory authorities.
- Study Sharepoint/study directory updates and the Global Vendor Site List etc.
- Independently performs core Global Trial Associate (GTA)



tasks and escalates/pushes back/delegates appropriately.
- Simple studies or studies in closure phase may be managed in alignment with OPL or GTL.
- Reviews vendor invoices and lead approval process or submits to GTLs for approval (as needed); manages accruals and LSD/SOW changes.
- Actively contributes to study meetings by leading assigned topics/components.
- Assist the Global Trial Lead (GTL) in driving study execution.
- Contributes to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications.
- Flexibility to work on various trials at varying stages/complexity with minimal guidance as needed.
- Understands strategy and decision making at program level and their impact on the studies.
- Ability to contribute to initiatives for process development and improvement.
- Ability to assess a situation and identify path forward with the appropriate resources.
- Understands interdependence of tasks assigned.
- Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
- Supports study specific CSR appendices, as needed.
- Manages vendors and site payment processing and tracking.
- Lead assigned study closure/archival activities during study closure phase.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Principal Global Trial Associate (Hyderabad)
🏢 Bristol-Myers Squibb
📍 Hyderabad